APOMORPHINE HYDROCHLORIDE 10 Mg/Ml Solution for Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
APOMORPHINE HYDROCHLORIDE
Available from:
Archimedes Pharma UK Limited
INN (International Name):
APOMORPHINE HYDROCHLORIDE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2012-03-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apomorphine hydrochloride 10mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg apomorphine hydrochloride
2ml contains 20mg apomorphine hydrochloride
5ml contains 50mg apomorphine hydrochloride
Sodium metabisulphite 1 mg/ml
Sodium 0.3 mg/ml (maximum)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection/ infusion
A clear, colourless to pale yellow solution. pH 3 – 4
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease which persist
despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine
agonists.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apomorphine 10mg/ml solution for injection is for subcutaneous use by intermittent bolus injection. Apomorphine
10mg/ml solution for injection may also be administered as a continuous subcutaneous infusion by minipump and/or
syringe driver. Apomorphine 10mg/ml solution for injection may be diluted with sodium chloride 9mg/ml (0.9%)
solution for injection or Water for Injections.
APOMORPHINE MUST NOT BE USED VIA THE INTRAVENOUS ROUTE.
Dosage
ADULTS
Administration
_SELECTION OF PATIENTS SUITABLE FOR APOMORPHINE 10MG/ML SOLUTION FOR INJECTION_
Patients selected for treatment with Apomorphine 10mg/ml solution for injection should be able to recognise the onset
of their ‘off’ symptoms and be capable of injecting themselves or else have a responsible carer able to inject for them
when required.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/03/2012_
_CRN 2
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